NCT00000583

Brief Summary

To determine the efficacy of a hepatitis vaccine in preventing hepatitis B.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 1978

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1978

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1980

Completed
19.4 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

November 26, 2013

Status Verified

April 1, 2012

First QC Date

October 27, 1999

Last Update Submit

November 25, 2013

Conditions

Hepatitis BHepatitis, Viral, HumanLiver Diseases

Interventions

hepatitis B vaccinesBIOLOGICAL

Eligibility Criteria

Age18 Years - 36 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Men at high risk for hepatitis B virus infection, 36 years of age or younger, no recent symptoms of hepatitis, blood specimen negative for HBsAg, anti-HBs and anti-HBe.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Szmuness W, Stevens CE, Harley EJ, Zang EA, Oleszko WR, William DC, Sadovsky R, Morrison JM, Kellner A. Hepatitis B vaccine: demonstration of efficacy in a controlled clinical trial in a high-risk population in the United States. N Engl J Med. 1980 Oct 9;303(15):833-41. doi: 10.1056/NEJM198010093031501.

    PMID: 6997738BACKGROUND

MeSH Terms

Conditions

Hepatitis BHepatitis, Viral, HumanLiver Diseases

Interventions

Hepatitis B Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitisDigestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

November 1, 1978

Study Completion

June 1, 1980

Last Updated

November 26, 2013

Record last verified: 2012-04